Correspondence 0001493152-23-023172 from BioLingus (Cayman) Ltd (CIK 0001966522)
BioLingus (Cayman) Ltd (CIK 0001966522)
Date: June 30, 2023 · CIK: 0001966522 · Accession: 0001493152-23-023172
AI Filing Summary & Sentiment
Referenced dates: June 20, 2023
Letter
Securities and Exchange Commission Division of Corporate Finance Office of Life Sciences BioLingus (Cayman) Limited Amendment No. 2 to Draft Registration Statement on Form F-1 Submitted June 12, 2023 CIK No. 0001966522
Dear Messrs. Xiao, Kuhar, Howes and Drory,
On behalf of our client, BioLingus (Cayman) Limited (the “Company”), we submit to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) this letter setting forth the Company’s responses to the comments contained in the Staff’s letter dated June 20, 2023. Concurrently with the submission of this letter, the Company is submitting its revised registration statement on Form F-1 (the “Revised Registration Statement”) and the related exhibits via EDGAR to the Commission.
The Staff’s comments are repeated below and are followed by the Company’s responses. We have included page references in the Revised Registration Statement where the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth in the Registration Statement.
* * *
Amendment No. 2 to Draft Registration Statement on Form F-1
Prospectus Summary
Our Products, page 7
1. Please disclose here and in the business section, if true, that you will not be able to begin marketing your Semaglutide Sublingual candidate, if approved, until patent protection on semaglutide expires. Your revised disclosure should also clearly indicate the dates semaglutide’s patent protection expires, as you have provided in your response to prior comment 11.
Response:
Responsive to the Staff’s comments, we have included the following disclosure on pages 7 and 88 of the Revised Registration Statement:
“The patent registered under The Patent Cooperation Treaty (PCT) for Semaglutide is PCT WO2006097537 titled Acylated GLP-1 compounds. The filing date is March 20, 2006 and the patent is set to expire on March 20, 2026 and subject to a five year extension by the applicant holder. As such, we will not begin marketing our Semaglutide Sublingual candidates, if approved, until March 20, 2026, and if extension is being exercised, until March 20, 2031.”
Business, page 84
2. We note your response to prior comment 5 and reissue in part. We continue to note your references to outside publications, such as, “(Kleinert et al., 2018)” and “(Smeekins et al, 2021)” but disclosure does not appear to describe the material details of these referenced studies. Please further revise your disclosure to discuss the material details of the studies, including, for example only, the sponsor, type of study, trial design and objective results.
Response:
The previous citations of Kleinert et al., 2018 and Smeekins et al, 2021 were to clarify, respectively, the purpose of and context for using a DIO mouse model and a peanut allergy mouse model, which are used routinely around the world by researchers as a way to study type 2 diabetes and peanut allergy, respectively. These references do not contain any material information related to the specific testing of the Company’s technology nor do they contain any actual data, new experimental work or statistical analyses. To avoid any such implications, these references have now been removed.
Our Products, page 87
3. We note your response to prior comment 6, but do not note any revised disclosure responsive to this comment. Please revise your discussion of the 505(b)(2) regulatory pathway to provide a more fulsome description of the specific, material studies and results you intend to rely on in pursuing this pathway, including identifying the parties that performed these studies and a discussion how the studies were performed, or advise.
Response:
We have provided a more fulsome discussion of the specific, material studies and results the Company intends to reply on in pursuing the 505(b)(2) regulatory pathway in the table beginning on page 88 of the Revised Registration Statement.
If you have any questions regarding the Revised Registration Statement, please contact the undersigned by phone at (212) 930 9700 or via e-mail at btan@srf.law.
Very
truly yours,
SICHENZIA
ROSS FERENCE LLP
Show Raw Text
CORRESP
1
filename1.htm
June
30, 2023
Li
Xiao/ Kevin Kuhar
Tyler
Howes/ Jason Drory
Securities
and Exchange Commission
Division
of Corporate Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
BioLingus
(Cayman) Limited
Amendment
No. 2 to
Draft
Registration Statement on Form F-1
Submitted
June 12, 2023 CIK No. 0001966522
Dear
Messrs. Xiao, Kuhar, Howes and Drory,
On
behalf of our client, BioLingus (Cayman) Limited (the “Company”), we submit to the staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) this letter setting forth the Company’s responses to the comments
contained in the Staff’s letter dated June 20, 2023. Concurrently with the submission of this letter, the Company is submitting
its revised registration statement on Form F-1 (the “Revised Registration Statement”) and the related exhibits via EDGAR
to the Commission.
The
Staff’s comments are repeated below and are followed by the Company’s responses. We have included page references in the
Revised Registration Statement where the language addressing a particular comment appears. Capitalized terms used but not otherwise defined
herein have the meanings set forth in the Registration Statement.
*
* *
Amendment
No. 2 to Draft Registration Statement on Form F-1
Prospectus
Summary
Our
Products, page 7
1.
Please disclose here and in the business section, if true, that you will not be able to begin marketing your Semaglutide Sublingual
candidate, if approved, until patent protection on semaglutide expires. Your revised disclosure should also clearly indicate the
dates semaglutide’s patent protection expires, as you have provided in your response to prior comment 11.
Response:
Responsive
to the Staff’s comments, we have included the following disclosure on pages 7 and 88 of the Revised Registration Statement:
“The
patent registered under The Patent Cooperation Treaty (PCT) for Semaglutide is PCT WO2006097537 titled Acylated GLP-1 compounds. The
filing date is March 20, 2006 and the patent is set to expire on March 20, 2026 and subject to a five year extension by the applicant
holder. As such, we will not begin marketing our Semaglutide Sublingual candidates, if approved, until March 20, 2026, and if extension
is being exercised, until March 20, 2031.”
Business,
page 84
2.
We note your response to prior comment 5 and reissue in part. We continue to note your references to outside publications, such as,
“(Kleinert et al., 2018)” and “(Smeekins et al, 2021)” but disclosure does not appear to describe the
material details of these referenced studies. Please further revise your disclosure to discuss the material details of the studies,
including, for example only, the sponsor, type of study, trial design and objective results.
Response:
The
previous citations of Kleinert et al., 2018 and Smeekins et al, 2021 were to clarify, respectively, the purpose of and context for using
a DIO mouse model and a peanut allergy mouse model, which are used routinely around the world by researchers as a way to study type 2
diabetes and peanut allergy, respectively. These references do not contain any material information related to the specific testing of
the Company’s technology nor do they contain any actual data, new experimental work or statistical analyses. To avoid any such
implications, these references have now been removed.
Our
Products, page 87
3.
We note your response to prior comment 6, but do not note any revised disclosure responsive to this comment. Please revise your
discussion of the 505(b)(2) regulatory pathway to provide a more fulsome description of the specific, material studies and results
you intend to rely on in pursuing this pathway, including identifying the parties that performed these studies and a discussion how
the studies were performed, or advise.
Response:
We
have provided a more fulsome discussion of the specific, material studies and results the Company intends to reply on in pursuing the
505(b)(2) regulatory pathway in the table beginning on page 88 of the Revised Registration Statement.
If
you have any questions regarding the Revised Registration Statement, please contact the undersigned by phone at (212) 930 9700 or via
e-mail at btan@srf.law.
Very
truly yours,
SICHENZIA
ROSS FERENCE LLP
/s/
Benjamin Tan
Benjamin
Tan Esq.
1185
Avenue of the Americas | 31st Floor | New York, NY | 10036
T
(212) 930 9700 | F (212) 930 9725 | WWW.SRF.LAW